Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.

SOARING FUEL PRICES CONTINUE TO AFFECT INDONESIAN DRUG MARKET

The Indonesian association of pharmaceutical companies, GP Farmasi,
is continuing its pessimistic outlook concerning the country's drug market,
forecasting that growth will stand at only 5% this year and that total sales
will fail to reach its target of IDR23trn (US$2.23bn).

Industry observers blame the current slump in the market on a 125% hike in
fuel prices in October, which has hit consumer spending power. In 2004, Indonesia's
drug market expanded by 25%. The current figure of 5% is the lowest since the
Asian economic crisis of 1997.

Earlier this year, the weakening of the Indonesian Rupiah against the US dollar
led to local drugmakers issuing threats of a 10-15% price hike. The currency's
value has a strong influence on the drug market, as roughly 90% of drug raw
materials used in manufacturing are imported. Raw materials account for around
30% of drug production costs.

According to industry observers, the continuing rise in fuel prices will only
make the situation worse and could lead to a number of foreign drugmakers pulling
out of the country.